Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty.

In this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert.

Some of the highlights of the show include:

●Most noticeable change is a broader definition of what qualifies as a medical device to include prediction and prognosis of diseased state.
●SaMD classification changes are drastic but vague following MDR implementation.
●Gap analysis should be performed to identify changes that companies need to make to conform with changes.
●Groups that will most likely experience the greatest impact due to classification and qualification changes:
○Products on market in EU as Class I software will be uplisted as Class IIa.
○Products that provide clinical information for informed clinical decisions.
●Timeline and Some Next Steps: Demonstrate conformance, update quality management system (QMS), notify regulatory body to MDR by May 25, 2020.
●Plan, prioritize, and understand your regulatory conformance strategy going forward.
●Compare and Contrast EU MDR and US FDA: Developing regulatory framework in different directions, but share consensus on sensitive nature and usage.